Process Engineer

Location: Madison, Wisconsin (Onsite)

* Strong MSAT experience in GMP manufacturing environments

* Hands-on experience in biologics drug substance manufacturing

* Core expertise in technology transfer from process development to manufacturing

* Experience in process development, scale-up, and manufacturing process design

* Experience creating Master Batch Records (MBRs)

* Knowledge of deviations, impact assessments, and Quality Management Systems (QMS)

* Understanding of QTPP (Quality Target Product Profile) and GMP requirements

* Practical experience with both upstream and downstream processes

* Strong client-facing, communication, and interpersonal skills

Important:

* This is a process-focused role, NOT a validation role.

* Strong hands-on process experience is essential.

* Candidates should be able to work independently with minimal technical training.